Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.

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01 120050831-19-A-11-02
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Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-22
Pay. Date : 2013-01-11
DMF Number : 13749
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : CEP 2002-156 - Rev 06
Issue Date : 2024-08-22
Type : Chemical
Substance Number : 813
Status : Valid
NDC Package Code : 61303-111
Start Marketing Date : 2007-06-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Daewoong Bio Co., Ltd.
Registration Date : 2019-04-04
Registration Number : 20050831-19-A-15-05(3)
Manufacturer Name : Centrient Pharmaceuticals Spain S.A.
Manufacturer Address : C/Ripolles, n2 Poligono Industrial URVASA Santa Perpetua de Mogoda 08130 BARCELONA SPAIN (POBox 425, 2600 AK Delft, The Netherlands)
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-19-A-15-05
Manufacturer Name : Centrient Pharmaceuticals Spain S.A.
Manufacturer Address : C/Ripolles, n2 Poligono Industrial URVASA Santa Perpetua de Mogoda 08130 BARCELONA SPAIN (POBox 425, 2600 AK Delft, The Netherlands)
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
NDC Package Code : 61303-715
Start Marketing Date : 2007-06-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Daewoong Pharmaceutical Co., Ltd.
Registration Date : 2015-05-12
Registration Number : 20050831-19-A-15-05(2)
Manufacturer Name : Centrient Pharmaceuticals Spain S.A.
Manufacturer Address : C/Ripolles, n2 Poligono Industrial URVASA Santa Perpetua de Mogoda 08130 BARCELONA SPAIN (POBox 425, 2600 AK Delft, The Netherlands)
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17106
Submission : 2004-01-14
Status : Active
Type : II
Certificate Number : CEP 2002-234 - Rev 03
Issue Date : 2024-09-06
Type : Chemical
Substance Number : 813
Status : Valid

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19290
Submission : 2006-03-21
Status : Active
Type : II
Date of Issue : 2025-07-07
Valid Till : 2028-07-31
Written Confirmation Number : WC-0048
Address of the Firm :
Registrant Name : Pampia Co., Ltd.
Registration Date : 2024-07-30
Registration Number : 20120106-19-A-256-09(3)
Manufacturer Name : Lupin Limited
Manufacturer Address : Plot No. 9,123,123/1, 124&125 GIDC Estate, Ankleshwar, 393 002, Bharuch Gujarat state, India

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12894
Submission : 1998-03-11
Status : Inactive
Type : II
Certificate Number : R1-CEP 1998-019 - Rev 00
Issue Date : 2003-12-18
Type : Chemical
Substance Number : 813
Status : Withdrawn by Holder

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13761
Submission : 1998-09-01
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13566
Submission : 1998-09-01
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13220
Submission : 1998-04-30
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13638
Submission : 1998-09-01
Status : Inactive
Type : II

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